样品前处理技术在药物元素杂质分析的应用探讨

Application of Sample Pretreatment Technology in Elemental Impurity Analysis of Drugs

元素杂质分析贯穿于药品研发、生产及稳定性研究过程,是药品质量控制的关键项目。合适的样品前处理技术不仅可以提高分析方法的检测限,还可以保证元素杂质分析结果的准确性。通过结合国内外药典元素杂质分析测试通则,对供试品理化性质、待测元素性质和研究目的进行分析,综述了元素杂质分析中样品前处理技术的选择。旨在为药物研发人员提供可靠元素杂质样品前处理技术选择依据,从分析方法开发源头上确保科学性与合理性,为药品工艺开发、包装选择、成品质量评价和限度控制提供准确可靠的检测数据。

The elemental impurity analysis is an important aspect of the drug quality control in pharmaceutical development,production,and stability research.Suitable sample pretreatment technology can not only improve the detection limit of the analytical method,but also ensure the accuracy of the analysis results of elemental impurities.In this article,on the basis of elemental impurity analysis general principles in domestic and foreign pharmacopoeias,the selection and study of pretreatment techniques for elemental impurity analysis are summarized,according to sample physicochemical properties,the properties of the elements to be measured and the research purpose.Thus,this article aims to help provide reliable selection basis of sample pretreatment technology in elemental impurity analysis of drugs and ensure scientificity and rationality in the source of analysis method development,providing accurate and reliable data for pharmaceutical process development,packaging selection,quality evaluation of drug and limit control.